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FDA 510(k)

ULTRASOUND SCANNER 2002

K-Number: K943315 · 1996-02-09

ApplicantB&K Medical
Decision Date1996-02-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SCANNER 2002 is the device name listed in this FDA 510(k) record. The listed applicant is B&K Medical. It received FDA 510(k) clearance on 1996-02-09 under 510(k) number K943315. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND SCANNER 2002?

ULTRASOUND SCANNER 2002 is a medical device that received FDA 510(k) clearance on 1996-02-09. The listed applicant is B&K Medical. The 510(k) number is K943315.

When did ULTRASOUND SCANNER 2002 receive FDA 510(k) clearance?

ULTRASOUND SCANNER 2002 received FDA 510(k) clearance on 1996-02-09, under 510(k) number K943315.

Who is the listed applicant for ULTRASOUND SCANNER 2002?

The FDA 510(k) record lists B&K Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASOUND SCANNER 2002?

The FDA product code for ULTRASOUND SCANNER 2002 is IYO.

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Other records listing B&K Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K926332DIAGNOSTIC ULTRASOUND SYSTEM, TYPE 3535, MODIFIEDK933056DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIEDK802878K-KATH URETHRAL CATHETER INTRODUCER

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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